The Medicines Act 1968 (Amendment) Regulations 1992

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Medicines Act 1968 (“the Act”), thereby implementing, insofar as they require the amendment of the Act, parts of Council Directives—

• 89/341/EEC relating to the approximation of provisions relating to proprietary medicinal products (OJ No. L142 25.5.89, p. 11);

• 89/342/EEC relating to immunological medicinal products (OJ No. L142, 25.5.1989, p. 14);

• 89/343/EEC relating to radiopharmaceuticals (OJ No. L142 25.5.1989, p. 16); and 89/381/EEC relating to medicinal products derived from human blood or human plasma (OJ No. L181, 28.6.1989, p. 44);

which each extend the scope of Council Directives 65/65/EEC (OJ No. 22, 9.2.1965, p. 369/65) and 75/319/EEC (OJ No. L147, 9.6.1975, p. 13) on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, to cover products which had previously been excluded from the scope of the 1965 Directive by Article 34 of Council Directive 75/319/EEC.

The amendments in regulation 2 make licensable under section 7(5)(b) of the Act (product licences) certain products for human use — immunological products, medicinal products based on human blood or blood constituents, and medicinal products based on radioactive isotopes (other than isotopes which are sealed sources).

Regulation 3 makes consequential amendments to section 8 of the Act and implements, in part, article 3 of 89/341/EEC.

Regulation 4 provides that the Regulations do not render unlawful anything done before 31st December 1992 in relation to products which were sold or supplied or procured to be sold, supplied, manufactured or assembled at any time before, and were on the United Kingdom market immediately before, the Regulations came into force.